Tenpoint Therapeutics Submits First International NDA for BRIMOCHOL PF Presbyopia Treatment in South Korea
核心洞察
Tenpoint Therapeutics (搜索)' partner Kwangdong Pharmaceutical has submitted a New Drug Application for BRIMOCHOL PF (搜索) to South Korea's MFDS, marking the first regulatory submission outside the United States for this presbyopia (搜索) treatment.
The submission is supported by positive Phase 3 BRIO-II study results showing statistically significant three-line improvement in near vision without distance vision loss, with no serious treatment-related adverse events in over 70,000 treatment days.
BRIMOCHOL PF (搜索) is designed as the first and only combination eye drop to address presbyopia (搜索), a condition affecting approximately two billion people globally.
Tenpoint Therapeutics (搜索) has achieved a significant regulatory milestone with the submission of a New Drug Application (NDA) for BRIMOCHOL PF (搜索) to South Korea's Ministry of Food and Drug Safety (MFDS), marking the first international regulatory filing for this investigational presbyopia (搜索) treatment. The submission was made through the company's partnership network, with Zhaoke Ophthalmology (搜索) supporting local partner Kwangdong Pharmaceutical Co., Ltd. (搜索) (KDP) in the filing process.
Pivotal Trial Data Supports Regulatory Submission
The South Korean NDA submission is backed by compelling clinical evidence from two Phase 3 pivotal studies. The BRIO-I study demonstrated the benefit of the combination therapy over individual monotherapy components, meeting regulatory requirements for fixed-dose combination approval. More significantly, the vehicle-controlled BRIO-II study showed BRIMOCHOL PF (搜索) achieved all primary near vision improvement endpoints with statistically significant three-line or greater improvement in binocular uncorrected near visual acuity (BUCNVA), while maintaining binocular uncorrected distance visual acuity (BUCDVA) without loss of one line or more.
The safety profile proved equally impressive, with no serious treatment-related adverse events observed across over 70,000 treatment days monitored during the BRIO-II study, establishing a robust safety foundation for regulatory review.
First-in-Class Combination Therapy for Global Presbyopia Burden
BRIMOCHOL PF (搜索) represents a novel pupil-modulating (搜索) therapeutic designed to be the first and only combination eye drop addressing presbyopia (搜索)-related near vision loss. The condition affects approximately two billion people globally, representing a substantial unmet medical need in ophthalmology.
"We believe BRIMOCHOL PF (搜索) has the potential to become a best-in-class treatment for people with presbyopia (搜索), and the NDA filing in South Korea is an important step in our efforts to make it available to patients around the world," said Henric Bjarke, Chief Executive Officer of Tenpoint Therapeutics (搜索).
Strategic Asia-Pacific Market Entry
The South Korean submission represents the initial phase of a broader Asia-Pacific commercialization strategy. Dr. Li Xiaoyi (Benjamin), Chairman of the Board, Executive Director and CEO of Zhaoke Ophthalmology (搜索), emphasized the strategic importance of this milestone: "Together with Tenpoint Therapeutics (搜索) and KDP, we are excited about this milestone, which marks a critical first step in our broader Asia-Pacific strategy. Our partnerships provide us with a strong distribution and commercialization framework, that we believe will enable us to effectively bring BRIMOCHOL PF (搜索) to the millions of presbyopia (搜索) patients in South Korea and across the Asia-Pacific region."
KDP will assume responsibility for manufacturing and distribution of BRIMOCHOL PF (搜索) in South Korea, leveraging its established pharmaceutical infrastructure and market presence as one of the top 10 pharmaceutical companies in Korea.
Dual-Market Regulatory Timeline
While advancing in South Korea, BRIMOCHOL PF (搜索) maintains momentum in the United States, where an NDA is currently under FDA review. The company has received a Prescription Drug User Fee Act (PDUFA) date of January 28, 2026, from the U.S. Food and Drug Administration, setting up potential dual-market approvals within the coming year.
This coordinated regulatory approach positions Tenpoint Therapeutics (搜索) to address presbyopia (搜索) patients across multiple major markets simultaneously, potentially accelerating global access to this novel therapeutic approach for age-related vision decline.